Known bladder endoprostheses comprise a balloon casing made with an impermeable layered silicone membrane.
Such casing is sufficiently rigid so as to stably keep its shape and flexible to be able to be manually compressed to ensure that it empties.
The casing has a connection element located at a lower portion of the casing to connect with the patient's urethra. Similarly, two connection bodies are located at the top to enable connection with the ureters.
These connections are achieved by suturing or by simply interlocking.
Following the implant of the endoprosthesis in the patient, there is the formation of a musculo-fibrous tissue layer (not impermeable) around the casing. In such a manner, a neobladder is generated around the endoprosthesis.
Since the endoprostheses of known type are permanent, complications can occur even after the complete rehabilitation of the patient.
Indeed, it may occur that an infection hits the neobladder in an accidental manner or following the use of catheters.
In such case, a suitable antibiotic treatment is necessary. Such drugs are effective in extinguishing the bacterial loads nested in biological tissue and have poor or even zero effect on bacterial loads nested on artificial materials like those that make up the casing. Disadvantageously, therefore, endoprostheses of known type can represent an obstacle to the effectiveness of antibiotic treatments.
Other solutions of bladder endoprosthesis are disclosed in WO2011/140137 which describes a matrix or scaffold, rigid or flexible and having a substantially round or scalloped or star shaped shape suitable to define, when implanted, the shape of bladder, with said matrix or scaffold used for the reconstruction of a bladder and such that, after the biodegradation of said matrix or scaffold, the reconstructed bladder works in a fashion similar to a natural bladder.
Another known solution is disclosed in WO2007/095193 which describes a scaffold suitable for organ reconstruction and augmentation and, in particular, it discloses a method and the materials for tissue and organs reconstruction, repair, augmentation and replacement, said material suitable to be used with patient having defect in urogenital tissues or organs; furthermore, it is disclosed an embodiment wherein the artificial bladder comprises hemispherical portions or valves symmetrical one with respect to the other and wherein said portions comprises external flanges suitable for manipulating the portions prior or during the surgery and to allow the sealing of said two portions.
The document MI2012A001709 discloses an endoprosthesis of artificial bladder which comprises a multilayered enclosure having a balloon shape and which is sufficiently rigid to keep its shape during the reconstruction process.
Another known document, WO98/50100, discloses a system and a method for promoting the growth or the expansion of biological tissue and, more in particular, it teaches the use of a device for seeding fluid under pressure in a balloon inserted in a interstitial cavity of the human body so as to allow a tissue expansion of said interstitial cavity suffering from pathology such as a bladder having an insufficient volume/capacity or where it is required perform an expansion of the urethra or similar.
Another known solution is disclosed in WO2007/075545, which discloses the use of an expandable balloon suitable to perform a drainage of a cavity wherein said balloon is inserted.
All said known solutions are complex not only under the constructional point of view but they are also complex considering the process and method on implantation.